Classifications

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  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
  • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
• • A—HUMAN NECESSITIES
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  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/02—Inorganic materials
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  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/04—Macromolecular materials
  • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• • A—HUMAN NECESSITIES
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  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• • A—HUMAN NECESSITIES
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  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M25/104—Balloon catheters used for angioplasty
• • G—PHYSICS
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• • G—PHYSICS
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  • G01S—RADIO DIRECTION-FINDING; RADIO NAVIGATION; DETERMINING DISTANCE OR VELOCITY BY USE OF RADIO WAVES; LOCATING OR PRESENCE-DETECTING BY USE OF THE REFLECTION OR RERADIATION OF RADIO WAVES; ANALOGOUS ARRANGEMENTS USING OTHER WAVES
  • G01S7/00—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00
  • G01S7/52—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00 of systems according to group G01S15/00
  • G01S7/52017—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00 of systems according to group G01S15/00 particularly adapted to short-range imaging
  • G01S7/52023—Details of receivers
  • G01S7/52036—Details of receivers using analysis of echo signal for target characterisation
  • G01S7/52038—Details of receivers using analysis of echo signal for target characterisation involving non-linear properties of the propagation medium or of the reflective target
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  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B10/04—Endoscopic instruments, e.g. catheter-type instruments
  • A61B2010/045—Needles
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  • A61B2017/3413—Needle locating or guiding means guided by ultrasound
• • A—HUMAN NECESSITIES
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  • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
  • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
  • A61B2034/2046—Tracking techniques
  • A61B2034/2063—Acoustic tracking systems, e.g. using ultrasound
• • A—HUMAN NECESSITIES
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  • A61B2034/2046—Tracking techniques
  • A61B2034/2065—Tracking using image or pattern recognition
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  • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
  • A61B90/37—Surgical systems with images on a monitor during operation
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  • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
  • A61B2090/3925—Markers, e.g. radio-opaque or breast lesions markers ultrasonic
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  • A61B8/48—Diagnostic techniques
  • A61B8/485—Diagnostic techniques involving measuring strain or elastic properties
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
  • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01S—RADIO DIRECTION-FINDING; RADIO NAVIGATION; DETERMINING DISTANCE OR VELOCITY BY USE OF RADIO WAVES; LOCATING OR PRESENCE-DETECTING BY USE OF THE REFLECTION OR RERADIATION OF RADIO WAVES; ANALOGOUS ARRANGEMENTS USING OTHER WAVES
  • G01S7/00—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00
  • G01S7/52—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00 of systems according to group G01S15/00
  • G01S7/52017—Details of systems according to groups G01S13/00, G01S15/00, G01S17/00 of systems according to group G01S15/00 particularly adapted to short-range imaging
  • G01S7/52023—Details of receivers
  • G01S7/52036—Details of receivers using analysis of echo signal for target characterisation
  • G01S7/52038—Details of receivers using analysis of echo signal for target characterisation involving non-linear properties of the propagation medium or of the reflective target
  • G01S7/52039—Details of receivers using analysis of echo signal for target characterisation involving non-linear properties of the propagation medium or of the reflective target exploiting the non-linear response of a contrast enhancer, e.g. a contrast agent

Definitions

• the invention relates to an apparatus, system, and method for increasing object visibility using ultrasound imagery.
• the apparatus includes novel features to facilitate a distinctive visual fingerprint using ultrasound.
• Standard ultrasound imagery is based on object reflectance due to acoustic impedance mismatch. Ultrasound machines also have the ability to detect and superimpose on the image the changes in frequency of the reflected wave with respect to the transmitted one. Ultrasound machines are able to work in a variety of methods. Doppler imagery is commonly used to detect blood flow which causes a shift in the ultrasound frequency of the value shown in the equation
• an ultrasound imager translates the reflected signal to an image depending on the amplitude of the reflected wave, its time in flight and its frequency. The latter is sometimes affected by reverberations which the imager interprets as signals coming from a longer distance.
• ultrasound imaging is used to provide a noninvasive method of creating a visual image or signal of what constitutes an opaque or mostly opaque membrane, which can be used in many different circumstances, for example, diagnostic tests evaluating different issues ranging, for example, from fetal health to artery deterioration. Further, ultrasound imaging is often used to guide needles being used for many different medical purposes including biopsies.
• US 9,138,286 (assigned to NuVue Therapeutics Inc.) describes an interventional medical device for use with a motion-sensitive ultrasonic imaging system which is intended to determine the location of diagnostic or therapeutic probes in soft tissue.
• a two-axis flexing mechanism in the medical device induces an orbital movement of an elongate member of the device to vibrate. According to the patent, this motion causes local agitation of fluids and/or tissues surrounding the elongate member and the agitation is visible on an ultrasound system sensitive to motion.
• NuVue Therapeutics has FDA marketing approval for a product called "NuVue ColorMark Needle", which is intended to allow the visualization by ultrasound of a needle, such as a biopsy needle, inserted into the body.
• the product is a hand-held needle device consisting of a battery-operated single-use device that integrates and vibrates interventional biopsy needles.
• the operating principle of the device is that the needle is made to vibrate at low sonic frequencies which make it visible on a Doppler Color-flow system since the vibration of the needle appears as motion to the Doppler system.
• Some visualization systems exist for viewing ultrasound data. For example, RealView Imaging (Yokneam, Israel) provides a system for imaging of SD structures generated from medical SD volumetric data using interference-based holography.
• the invention relates to medical devices having a marker which can be detected with ultrasound imaging wherein the marker comprises a vibrating membrane, reflective of ultrasonic waves.
• the marker may further comprise a housing wherein the membrane is attached to the housing at its edges.
• the vibrating membrane has an area and a thickness such that the membrane vibrates at a specific resonance frequency, amplitude, non-linearity, and reverberation period in response to a vibrating stimulation.
• Three preferred types of ultrasound detection are preferred, that is, color Doppler imagery, acoustic radiation force impulse (or "ARFI") imaging, and harmonic imagery. Other ultrasound methods may also be utilized.
• the marker comprises a housing and a vibrating membrane which may be an air-backed membrane.
• the membrane may be made of one or more suitable biocompatible materials such as silicon, titanium, or other similar biocompatible materials.
• the housing may also be made of one or more suitable biocompatible materials such as silicon, titanium, or other similar biocompatible materials.
• the invention relates to a detectable invasive medical device system comprising an invasive medical device and a marker having a membrane reflective to ultrasonic waves.
• the marker may be attached to any invasive medical device, that is, a device which is either implanted in a permanent or temporary manner, or a medical device inserted into the body.
• an invasive medical device may include a needle, a biopsy needle, catheter, angioplasty catheter, or other invasive or surgical device.
• the marker may be attached to a temporary or permanent implant such as, for example, a stent, heart valve, defibrillator, sensor, or other implant.
• the marker may be attached thereto via welding, adhesive, or other similar means or integrated into the device during manufacture.
• the marker may have a resonance frequency equal to that of the ultrasound imager of a harmonics-type ultrasound imaging.
• the marker may have a resonance frequency in the range accessible to color Doppler imagers.
• the marker may have a resonance frequency larger than that of the Doppler shift created by blood flow.
• the membrane has a resonance frequency accessible to ARFI imagers.
• the present invention also relates to a system comprising a marker device having a membrane and a housing, wherein the membrane is reflective of ultrasonic waves, and an ultrasound generating device.
• the membrane has an area and a thickness which allows the membrane to vibrate at a specific resonance frequency, amplitude, non-linearity, and reverberation period.
• the system includes an ultrasound generating device such as an ultrasound transducer.
• the ultrasound transducer preferably transmits at a frequency range corresponding to the resonance frequency of the membrane.
• the invention also relates to a method for using the system.
• the method includes the steps of (1) positioning the medical device having a marker membrane at a target position in a body cavity, (2) placing an ultrasound transducer on or near an outer surface of said target position to excite the marker membrane, and (3) detecting said excited marker vibration via a detectible signal indicating the location of the medical device.
• the method may use any of the embodiments of the marker or system described herein.
• FIG. 1A shows detection of true and false catheter tips using ultrasound.
• FIG. IB shows an ultrasound image of a possible false tip.
• FIG. 2A shows a side view of an exemplary air-backed membrane of the invention.
• FIG. 2B shows a front view of an exemplary air-backed membrane of the invention.
• FIG. 3 shows a needle incorporating an exemplary ultrasound marker.
• FIG. 4 shows a pacemaker incorporating an exemplary ultrasound marker.
• FIG. 5A shows an isometric view of an exemplary ultrasound marker of the invention.
• FIG. 5B shows a side view of an exemplary ultrasound marker of the invention.
• FIG. 5C shows a top view of an exemplary ultrasound marker of the invention.
• the invention relates to a medical device having an ultrasound marker.
• the marker comprises a membrane reflective of ultrasound waves.
• the invention also relates to systems and methods for using the ultrasound marker in detecting an invasive medical device.
• the ultrasound marker mounted on or integrated into the medical device is designed to have a specific resonance frequency which appears distinct in an ultrasound image.
• the resonance frequency can be determined by the geometric properties of the marker.
• the marker is preferably less than 0.50 mm 3 in size, having any suitable shape and dimension.
• One example marker is the sensor device described in U.S. Patent 6,770,032 to Kaplan which is incorporated herein in toto by reference. This marker may be similar to a sensor device comprising surfaces of 10-2000 micrometers in each dimension. In other embodiments, the marker is not dependent on pressure. Because the Kaplan sensor must be sensitive to pressure, it is required to have a ratio of thickness to diameter of approximately 1:100. The marker of the present invention does not require sensitivity to pressure.
• the membrane is most effective when the ratio of thickness to diameter is between 1:4 and 1:6, but in certain embodiments, the ratio of thickness to diameter is less than 1:100, and may be as low as 1:3, for example.
• the housing which protects the marker transfers the pressure and is largely transparent to ultrasound.
• the housing's main purpose is to protect the marker from deterioration which can occur within the body.
• Another example marker is the sensor device described in U.S. Patent 7,134,341 to Girmonsky.
• prior art sensors require short broadband ultrasonic pulses.
• the invention may use marker devices having longer broadband ultrasonic pulses. Such pulses can range from microseconds to continuous waves.
• the marker is incorporated into an invasive medical device by mounting said marker thereon or integrating into or onto the medical device.
• a body cavity includes any internal body space, organ, or lumen which is not visible from outside the body.
• the marker may be integrated into the medical device by being attached in one of a number of ways including welding, embedding or integrating during manufacture. Some devices will require markers be made of specific materials to prevent corrosion or to assist in bonding.
• An invasive medical device includes those used in surgical procedures or permanent or temporary implants including, for example, artificial joints, artificial hips, artificial knees, heart pacemakers, breast implants, intra-uterine devices, implanted screws, implanted pins, implanted plates, implanted rods, spine screws, pine rods, artificial spine disks, coronary stents, ear tubes, and vascular access ports. More generically, the invasive medical device is one used or placed inside a body cavity.
• the invention also relates to a method of detecting the invasive medical device using the ultrasonic marker.
• the method may comprise the steps of (a) placing an invasive medical device having a marker within a body cavity, including an artery, ear cavity, mouth, or injection site, for example; (b) directing ultrasonic waves from an outer surface of the body cavity toward the medical device using an ultrasonic transducer, causing the marker to vibrate at its resonance frequency; and (c) detecting the medical device and its location in the body cavity.
• the method of the invention may detect an implanted device and may include the steps of: (1) directing ultrasound waves from an outer surface of the body toward the implanted device having the marker; and (2) detecting signals from the marker thereby determining the location of the implanted device.
• Ultrasonic transducers convert standard AC electrical current into ultrasound waves, as well as the reverse.
• Ultrasonic transducers typically refer to piezoelectric transducers or capacitive transducers.
• Piezoelectric crystals may be used in that such crystals change size and shape when a voltage is applied. Specifically, AC voltage makes the piezoelectric crystals oscillate at a consistent frequency and produce ultrasonic sound. Because piezoelectric materials generate a voltage when force is applied to such materials, piezoelectric devices can also work as ultrasonic detectors. Some ultrasonic systems may use separate transmitters and receivers, while others may combine both functions into a single piezoelectric transceiver. Alternatively, capacitive transducers may use electrostatic fields between a conductive diaphragm and a backing plate to generate ultrasound waves. Both types of transducers are known in the art and may be used in the invention.
• the marker of the invention may, for example, be detected using color Doppler ultrasound, continuous wave Doppler imaging, ARFI imaging, or harmonic imaging ultrasound.
• Color Doppler imaging is a preferred ultrasonic technique for medical imaging because such imaging permits visualization of moving objects relative to a static background.
• Use of color Doppler imaging may require a physician to be able to aim the detection device accurately relative to the target.
• Measurement of Doppler shifts permits separation of moving objects from the background, such as movement of blood cells or the beating of the heart (as in an echocardiogram).
• the moving objects are assigned a color depending on the direction of their motion and the static background is depicted in grayscale.
• the marker of the present invention may be displayed as a distinct color in the image.
• a color Doppler-type ultrasonic diagnostic apparatus functions by detecting frequency shifts, caused by the Doppler effect of ultrasonic pulses transmitted toward an object being examined by means of frequency analysis of received echo signals, and displaying a distribution image of a flow of blood based on the detected results.
• the detectable frequency shift (hereinafter, referred to as a Doppler shift component) corresponds to a component of velocity in an ultrasonic beam direction.
• the marker may be detected using harmonic imaging.
• harmonic imaging the ultrasound system transmits and receives a sound pulse of a specific frequency.
• the returned signal in traditional ultrasound imaging is less intense than the transmitted signal, losing strength as the signal passes through tissue.
• harmonic imaging the signal returned by the target includes not only the transmitted fundamental frequency, but also signals of other frequencies - most notably, the harmonic frequency, which is twice the fundamental frequency. Once this combined fundamental/harmonic signal is received, the ultrasound system separates out the two components and then processes the harmonic signal alone.
• Harmonics are generated by the passage of the ultrasound scanner beam as the harmonic passes through tissue.
• the peaks and troughs of the transmitted pulse cause the target to alternatively expand and contract, distorting its shape. Because a target tissue, for example, is not linearly elastic, the tissue contracts less than it expands. During tissue contraction, tissue density increases, causing the peak of the sound wave to travel slightly faster than the trough. The result of this process, called non-linear propagation, is that the wave becomes progressively more asymmetrical. This asymmetrical distortion results in harmonics.
• the invention comprises a medical device having a marker which appears more prominently than tissue allowing easy detection.
• harmonics are generated predominantly by the main transmit beam.
• the region of maximal production of harmonics is at the focal zone because beam intensity is highest at that location. Little or no harmonics are produced by weak waves, such as side lobes, grating lobes, scattered echoes, and at the edges of the main ultrasound scanner beam. As a result, beams formed from harmonic signals have less noise, and improved contrast resolution.
• the resonance frequency of the marker of the invention may be designed to be the frequency of the transducer, which will cause it to appear more intensely and brighter on the ultrasound image.
• Tissue harmonic imaging using ultrasound scanners operate by transmitting a fundamental beam having a lower frequency.
• the resulting fundamental pulse propagates through tissue inside the body, and generates the higher frequency harmonic sound.
• Tissue harmonic imaging in ultrasound scanners forms the image primarily from the higher frequency harmonic sound. Echoes from the fundamental frequency are rejected and thus, are not used in generating the image. Indeed, if the higher amplitude fundamental echoes are not eliminated, the echoes degrade the image to the point that there is no benefit from tissue harmonic imaging. Further, the echoes cause much stronger signal, but are not relevant to the medical device. Advanced transmit beam formation and signal detection is preferred to produce good quality harmonic images.
• the medical device may be detected using ARFI imaging.
• ARFI acoustic radiation force impulse
• a single ultrasound transducer is used to both induce and monitor on-axis deformation in order to generate qualitative images of tissue stiffness.
• an ARFI pulse sequence consists of three pulse types: 1) reference pulses that precede the ARF burst and may be used as a baseline for tissue position, 2) pushing pulses that consist of a high-intensity impulse to displace the tissue, and 3) tracking pulses that monitor the tissue dynamics following the ARF burst.
• Tissue displacement is measured using correlation or phase-shift estimation techniques on raw RF data from the reference and tracking pulses.
• the pulse sequence and motion estimation is repeated at a number of lateral positions across the imaging field of view to build up a 3D data set consisting of tissue displacement as a function of axial position, lateral position and time.
• the membrane used as the ultrasonic marker may be an air-backed membrane.
• the air-backed membrane prevents acoustic leakage compared to other membranes.
• the air-backed membrane used in the present invention reduces or eliminates energy dissipation and reflects the ultrasound waves.
• the air-backed membrane is suspended on a frame to vibrate.
• the housing may form a geometric solid, and the air-backed membrane may be a cylinder attached thereto.
• a circular air-backed membrane may, for example, have the dimensions of approximately 0.3 to 2.0 mm diameter x 0.05 to 0.50 mm thickness.
• a circular air-backed membrane may, for example, have the dimensions of approximately 0.6 to 1.0 mm diameter x 0.1 to 0.20 mm thickness.
• the membrane of the invention is made of a biocompatible material such that the membrane is capable of reflecting ultrasound waves.
• the membrane substantially reflects ultrasound waves-- specifically, it may reflect greater than 90% of the ultrasound waves.
• the membrane may reflect up to or greater than 98% of the ultrasound waves.
• the reflective capacity of the membrane is one indicator of the quality of the membrane as a marker.
• a device comprising an ultrasound marker according to the present invention can be readily detected by ultrasound within a patient's body or body cavity during an invasive medical procedure.
• the invention can be used during a biopsy to guide the surgeon or another medical practitioner in the placement of medical instrumentation or apparatus such as biopsy needles, sensors, implants, or other items within the patient's body or body cavity in real time.
• the invention is also useful for improving visualization of catheters or catheter tips during transcatheter procedures such as tissue ablation for treatment of arrhythmia, transceptal puncture, implantation of sensors, and clipping of leaky mitral heart valves.
• Other uses of the invention will be apparent from the discussion below.
• FIG. 1A illustrated one issue with ultrasound imaging of catheters, i.e., the problem of "false tips".
• ultrasound as the imaging modality during transcatheter procedures
• identifying the actual placement of a catheter tip is frequently problematic.
• the ultrasound "cuts" through the three-dimensional space inside the patient's body in a single plane. Consequently, the ultrasound image will often show a false tip where the ultrasound plane cuts through the catheter instead of displaying the location of the real tip. This inadequacy can be seen in FIG. 1, where a catheter 150 having a tip is imaged via the ultrasound plane 160.
• the imaging system displays a false tip 155 which is where the ultrasound plane intersects the end of the catheter, whereas the true tip 165 is located below the ultrasound plane and is not visible on a display screen during the medical procedure. It is impossible to know whether the tip of the catheter (or other medical device) on the display screen is the true tip or a false tip via conventional ultrasound techniques, as shown in FIG. IB. Other medical devices besides catheters also have the same problem with display of false tips.
• FIG. IB shows an ultrasound image of the left atrium of the heart of an implantation in a porcine model using a conventional catheter tip. The locations of the catheter and the catheter tip in the ultrasound image are marked using arrows. Because of the inadequacies of ultrasound imaging as discussed above, it is impossible to know whether the catheter tip in FIG. IB is a true tip or a false tip.
• FIGs. 2A and 2B show the marker 102 of the invention which incorporates a membrane 104 that reflects ultrasound waves.
• the membrane 104 may be a thin air- backed membrane.
• Air-backed membranes may be made of any material, because air-backing reflects substantially all of ultrasound waves with any material (preferably between about 90% and 99%). (The term "about” as used herein is understood to mean an amount within l%-5% of the recited value).
• the marker 102 provides superior positional feedback to a needle or device. It does so by being calibrated to have a specific resonance frequency which differs from that of other objects in a body.
• the resonance frequency of the ultrasound marker is controlled by various attributes of the membrane 104 including its size, thickness and composition. Modification of the materials, membrane area 106, and membrane thickness 108 will alter the resonance frequency of the membrane 104 to be suitable for different purposes and/or circumstances.
• Embodiments of rectangular membranes may have a width and length of approximately 0.5 mm to 2.00 mm and a thickness of 0.05 mm to 0.8 mm.
• An exemplary rectangular membrane width and length may range from approximately 0.9 mm to 1.34 mm.
• the membrane thickness 108 may range from 0.1 mm to 0.45 mm. Modifying the physical characteristics of the membrane enables the manufacturer to choose the resonance frequency.
• suitable biocompatible materials are included within the scope of the invention where applicable.
• Non-limiting exemplary materials for the marker are a metal, a metal alloy, titanium, platinum, stainless steel, a shape memory alloy such as but not limited to NITINOL ® , silicon, glass, quartz, a ceramic material, a composite material, a metallic or non-metallic nitride, boron nitride, a carbide, a metal oxide, a non-metallic oxide, a polymer based material, and combinations thereof.
• the resonance frequency of the membrane is preferably in the range of frequencies made by traditional color Doppler ultrasound transducers.
• the practitioner may also use a second transducer calibrated to the resonance frequency of the membrane 104. This second transducer creates sound waves of the resonance frequency of the membrane.
• the second transducer may be placed 20-25 centimeters from the site of the medical device, which will cause the membrane 104 to vibrate at the resonance frequency, which, in turn, will cause the marker to appear in the color corresponding to its resonance frequency on the ultrasound images.
• the resonance frequency of the membrane 104 may be calibrated to be greater than the Doppler shift caused by blood flow. This difference in frequencies will cause the membrane 104 to vibrate at a greater frequency resulting in the membrane 104 displaying a different color than the rest of the image.
• the unique reverberation period of the membrane will provide a specific comet tail length because after a pulse is sent by the transducer, the reverberation results in a longer interpreted time of flight, which results in a spread of the marker image along the direction of transducer's axis.
• a filter can be added to the ultrasound image which removes the color response of blood flow, thereby enhancing the image clarity.
• the power of the ultrasound transmitter can be adjusted to change how prominently the marker 102 appears on the ultrasound image.
• markers 102 with different resonance frequencies and different color signatures may be added to different points of an object under imaging. Then, by changing the frequency created by the transducer, one can control the part of the object being emphasized on the ultrasound image.
• the value of the resonance frequency of the membrane is designed to be similar to the value of the ultrasound imager frequencies. Harmonic imagers transmit at the frequency/, and receive at the frequency 2/. Such transducers create sound waves of the resonance frequency of the membrane causing the membrane 104 to vibrate at that frequency. The marker 102 will vibrate at the same frequency more strongly than the surrounding areas and will appear more prominently in the ultrasound image. The amplitude of the signal produced by the marker at the excitation frequency will be a product of the non-linearity of the membrane.
• the value of the resonance frequency of the membrane is designed to be similar to the value of the ARFI imager frequencies. ARFI imagers transmit at the frequency /.
• such transducers create ultrasound waves of the resonance frequency of the membrane causing the membrane 104 to vibrate at that frequency.
• the marker 102 will vibrate at the same frequency more strongly than the surrounding areas and will appear more prominently in the ultrasound image.
• FIG. 3 shows an exemplary embodiment of a needle with a marker attached to said needle 202.
• the marker 206 is attached to a needle 204 by one of a number of possible methods including welding or embedding, for example. Embedding the marker may be preferable in certain embodiments in that embedding will help maintain the smooth edges of the needle 204.
• the invention further comprises a method of detecting a needle having a marker in a patient using an ultrasound transducer.
• a needle with a marker attached 202 can be used during ultrasonic guidance of needles while taking a biopsy or in other surgical procedures.
• a similar apparatus having a marker integrated onto a catheter may be used during angioplasty or other procedures using ultrasonic guidance. Similar apparatuses can also be used, for example, to aid guidance during: implantation of catheter deployed aortic and mitral valves; transeptal needle guidance for crossing into the left atrium; and/or ablation catheter guidance for electrophysiology.
• one such method comprises (a) inserting the needle having a marker 202 into a target; (b) positioning a first ultrasound transducer over the area of concern in accordance with standard ultrasonic guidance; (c) activating the marker either by activating a second transducer for color Doppler implementations or using the first transducer for harmonic implementations which in turn causes the marker to vibrate which is detectible; and (d) observing the marker on an ultrasound image.
• This method may be used with other devices having a marker. When viewing the needle having a marker 202 or other device on the ultrasound image, the marker will be easily visible, making navigation easier.
• the method may also relate to detection of implanted devices having a marker integrated therein or thereon.
• FIG. 4 shows an exemplary embodiment of a pacemaker 302 with a marker attached.
• the marker 306 is integrated onto a pacemaker 304 by one of a number of possible methods including, for example, welding, gluing, integrally manufacturing, or embedding during manufacture. Embedding during manufacture may be preferable for certain devices to help maintain the shape and form of the device 304. The particular location of the marker on the pacemaker may vary.
• the pacemaker 302 having a marker may be detected using ultrasound.
• the procedure is the same as described above for use with a marker embedded on a needle 202.
• Using the procedure with pacemaker 302 having a marker enables a user to easily find the implanted device when performing an ultrasound, making examinations non-invasive and efficient, particularly benefiting the patient when tracking an implant over a long period of time.
• FIG. 5A shows an isometric view of a marker 400 having an air-backed membrane 404 on a housing 402.
• FIG. 5B shows a side view of the embodiment of the marker 400 shown in FIG. 5A.
• FIG. 5C shows a top view of the embodiment of the marker 400 shown in FIG. 5A.
• the housing 402 forms a rectangular solid. It can range in size from about 100 micrometers squared to 250000 micrometers squared.
• the air-backed membrane 404 is a cylinder which rests on the housing 402. The air-backed membrane 404 may be centered on the housing 402.
• the marker of the present invention can be used for ultrasound imaging during any type of invasive medical procedure.
• the marker can be used with a vibrating medical device such as a vibrating needle for improved visualization of the needle under ultrasound conditions.
• the marker of the present invention can be used during 3D medical holography to assist the surgeon or doctor in visualizing the true position of a medical device in the body during an ultrasound-guided medical or surgical procedure such as (but not limited to) biopsy or implantation.
• an ultrasound-guided medical or surgical procedure such as (but not limited to) biopsy or implantation.
• Other uses of the inventive marker will be evident to those of ordinary skill in the art.

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• 2019
  • 2019-06-19 EP EP19790262.0A patent/EP3809979A2/de not_active Withdrawn
  • 2019-06-19 US US16/445,383 patent/US20190388062A1/en not_active Abandoned
  • 2019-06-19 WO PCT/IB2019/000796 patent/WO2019243896A2/en not_active Ceased
  • 2019-06-19 CN CN201980038845.0A patent/CN112739271A/zh active Pending
  • 2019-06-19 JP JP2020570947A patent/JP2021528166A/ja active Pending
• 2020
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